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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 211484

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NDA 211484 describes LEVORPHANOL TARTRATE, which is a drug marketed by Acertis Pharms, Hikma, Novitium Pharma, Specgx Llc, and Sun Pharm Inds Inc, and is included in five NDAs. It is available from seven suppliers. Additional details are available on the LEVORPHANOL TARTRATE profile page.

The generic ingredient in LEVORPHANOL TARTRATE is levorphanol tartrate. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the levorphanol tartrate profile page.

Summary for 211484

Tradename:	LEVORPHANOL TARTRATE
Applicant:	Acertis Pharms
Ingredient:	levorphanol tartrate
Patents:	0

Pharmacology for NDA: 211484

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 211484

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 211484

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	211484	ANDA	Virtus Pharmaceuticals, LLC	69543-417	69543-417-10	100 TABLET in 1 BOTTLE (69543-417-10)
LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	211484	ANDA	Bryant Ranch Prepack	72162-2309	72162-2309-1	100 TABLET in 1 BOTTLE (72162-2309-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Dec 13, 2018	TE:	AB	RLD:	No

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